Radio-pharmaceuticals are typically packaged in a standard way to reduce exposure to the end-user of the product. Most of these types of pharmaceuticals have short half-lives, so radioactive content can be extremely high to the operators during manufacturing and handling of these products. Packaging containers consists of several components, with the main component being lead. Lead has a very high density and provides excellent shielding characteristics for both gamma and beta emitting radio-pharmaceuticals. Lead is also very heavy and thus contributes to ergonomically related stress during manufacturing, assembly, and handling.
With reference to FIG. 1, a radio-pharmaceutical container 10 of the prior art typically includes an outer shell 12 that is typically formed from plastic and is both durable and cleanable. The outer shell 12 is durable to meet the requirements of the Department of Transportation (DOT). The outer shell 12 must contain and protect the inner contents of the package 10 during shipping and use of the product. The outer shell 12 is cleanable so that any radioactive contamination can be washed off of the surface. Radioactive contamination is a possibility due to the nature of the contents and the environment where the containers are used. The outer shell 12 typically has a label containing all of the product information such as; product name, manufacturing date, volume, specific activity, etc. The outer shell 12 is usually and injection molded component that contains sub-parts 12a and 12b that are assembled into a lower and upper assembly.
Container 10 further includes an inner shell 14 that fits within the outer shell 12. The inner shell 12 is typically manufactured from lead with a small percentage of antimony. The inner shell is designed to provide shielding of the radioactive contents of the container 10. The inner shell 14 is usually poured from molten lead into a negative void, or form. The inner shell 14 contains sub-parts 14a and 14b that are assembled into a cap 16 and base 18 by mating with outer shell sup-parts 12a and 12b, respectively.
The prior art container accommodates a product container 15, typically a vial, that is the primary holder of the product. It can be made of plastic or glass and can be sterile or non-sterile. Container 15 typically includes a pierceable septum across an open end, or mouth, thereof. Septum 17 allows a needle or cannula to pierce the septum and extend to the product fluid contained within container 15 for withdrawal. The product container 15 may be kept in the shipping container 10 during use to reduce exposure to the end-user.
Additionally, there may be an absorbent material placed in the container to absorb fluid if the product container is breached during shipment or use. There may be a cushioning material, such as a sponge, to protect the product container from shock during shipment or use. There may also be an inner sleeve that can be between an inner surface and the product container to segregate the product container from the lead of the radiation shield.
The outer shell 12 and inner shell 14 are fully formed by a mating cap 16 and base 18. The base 18 typically defines the container cavity 20 into which the vial 15 is placed. When the cap 16 and base 20 are mated, the cavity 20 is sealed and surrounded by the lead shielding material of inner shell 14a and 14b. After the drug product is manufactured, the product container, typically a vial, is placed into the container cavity 20 and the cap 16 is secured to the base 20. During end use of the product fluid in the vial 15, the cap 16 is removed and a syringe is used to pierce the septum 17 of the vial 15 for extraction of the desired amount of product fluid. Manipulation of the fluid requires the cap 16 to be removed, thus providing the path for radiation exposure to a user.
These packaging containers provide shielding from the activity of the radiopharmaceutical within during shipment and storage. However, once the container is opened, there can be exposure to both lead as well as to radiation shining out through the open storage cavity of the inner shell. Additionally, once the container is opened, the product container 15 is loose, or non-captive. Moreover, in order to visually check the amount of radioactive fluid remaining in the vial 15, an operator must lift the vial 15 out from cavity 20, further exposing the operator to activity shining out from the vial.
The art lacks a shielded container for a radiopharmaceutical which reduces operator exposure to the radiopharmaceutical during extraction of the radiopharmaceutical product and extraction of the product vial.